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No environmental monitoring samples taken since April...SQF audit due

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renzr79

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Posted 14 October 2020 - 07:44 PM

Hello all,

 

I recently came onboard to a food manufacturing facility as the FS & Reg Aff. Coordinator. This is my first exposure to the manufacturing sector and have spent months in training for SQF, HACCP, PCQI, FSVP, IA, etc. 

 

Have spent some time developing the COVID 19 plan as well as other tasks and requests for the facility and have not being able to leave the desk.

 

Also, have been updating the current SQF system and came across the EM program and realized no sampling have been conducted since early April. According to our program, we are to take samples twice a month. 

 

Is there a way we can successfully justify for the missing samples without compromise the SQF certificate during an audit? If there is no way and we are in danger of loosing our certification, please advise, because I do not want to be the on the chopping block for this.

 

Thanks.



TimG

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Posted 14 October 2020 - 07:57 PM

Hey Ren, first, take a deep breath. You can only fix things when you are aware of them. My suggestions on this:

  1. Open a non-conformance. As with any NC or CAPA program, document as much as you can what you found. For example, 'Was updating plan and found EM program was not being implemented' but go into as much detail as you think is needed (not too much, don't hang yourself).
  2. Get to work on fixing it NOW. That means reading the EM program, understanding what you 'say you are doing,' and then implementing anything necessary so you 'do what you say.'
  3. Document in the NC/CAPA the corrections you made in step 2
  4. Determine a root cause as to why #1 happened (why did no one else catch this, why did YOU not catch this until now) and document this
  5. Implement a corrective action for #4 so that the chances of it happening again are extremely low

This probably isn't going to stop a finding from SQF, but this will go a long way to how serious the auditor considers the finding.

Everyone makes mistakes. Own it, fix it, make sure it doesn't happen again.



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renzr79

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Posted 14 October 2020 - 08:28 PM

Thanks, Tim. Really, thank you. I am currently and actively working on getting this fixed following due process. My concern is this. Will the auditor consider this a critical item without any regards to all efforts to correct the violation and the effective implementation of CAPA? I have already been told if we score less than 96 in the coming audit my job could be on the line. If this is an unrealistic expectation, I need to know. Thanks again.



Charles.C

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Posted 15 October 2020 - 09:48 AM

Thanks, Tim. Really, thank you. I am currently and actively working on getting this fixed following due process. My concern is this. Will the auditor consider this a critical item without any regards to all efforts to correct the violation and the effective implementation of CAPA? I have already been told if we score less than 96 in the coming audit my job could be on the line. If this is an unrealistic expectation, I need to know. Thanks again.

So what is the current situation/longevity regarding Certification to SQF ?

 

You can find a few near-identical queries to this one on the Forum.

 

Offhand, IIRC,  forecasts have ranged from the auditor implementing a basic NC up to cancelling the audit until appropriate documentation was available.

 

I guess the context, eg Product/Process/History et al are all relevant.


Kind Regards,

 

Charles.C


TimG

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Posted 15 October 2020 - 01:17 PM

Thanks, Tim. Really, thank you. I am currently and actively working on getting this fixed following due process. My concern is this. Will the auditor consider this a critical item without any regards to all efforts to correct the violation and the effective implementation of CAPA? I have already been told if we score less than 96 in the coming audit my job could be on the line. If this is an unrealistic expectation, I need to know. Thanks again.

 

Take the scores from all previous audits, what's the low/high and average? That should help give you a range for your own sanity.

You are new in this position, and this is your 'first exposure to the manufacturing sector' which means your first SQF audit in a manufacturing environment. It's Good to receive a score of good (I think 86-95 is still 'good', isn't it? It's been a few years since I've been in an SQF facility) in your position. It's OK to receive 'complies.'

Looking at your position from the outside, the statement "I have already been told if we score less than 96 in the coming audit my job could be on the line" is a HUGE red flag to me. You want your relationship with your employer to be a healthy relationship. The statement you made, is not healthy. Hold yourself to a high standard, and work toward your goals to better yourself. Don't let some piss-ant middle manager, or executive committee, or owner bully you into getting themselves a higher bonus driven by the fear they instilled in you.



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Ted S

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Posted 15 October 2020 - 06:23 PM

Regarding your scenario with the upcoming audit and lack of EM data for the last six months, you will not score a 96. A good auditor will identify this non-compliance as a serious issue due to the importance of EM and this will show in the audit score. In addition, there is a high probability that the auditor will look at all key audit issues more critically. If a company states that they will do something with a specific frequency and do not do what their policy states, what else are they not doing? This will certainly raise a red flag to a good auditor. In addition, I find it unacceptable that you are being told that your job might be on the line if you do not achieve a high audit score. This is an unrealistic expectation for a new hire in a new role (and work environment) who is probably overwhelmed.



Peppin1981

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Posted 18 October 2020 - 12:38 PM

Hey Ren, first, take a deep breath. You can only fix things when you are aware of them. My suggestions on this:

  1. Open a non-conformance. As with any NC or CAPA program, document as much as you can what you found. For example, 'Was updating plan and found EM program was not being implemented' but go into as much detail as you think is needed (not too much, don't hang yourself).
  2. Get to work on fixing it NOW. That means reading the EM program, understanding what you 'say you are doing,' and then implementing anything necessary so you 'do what you say.'
  3. Document in the NC/CAPA the corrections you made in step 2
  4. Determine a root cause as to why #1 happened (why did no one else catch this, why did YOU not catch this until now) and document this
  5. Implement a corrective action for #4 so that the chances of it happening again are extremely low

This probably isn't going to stop a finding from SQF, but this will go a long way to how serious the auditor considers the finding.

Everyone makes mistakes. Own it, fix it, make sure it doesn't happen again.

 

Hi Renzr79.

 

Great advice from Tim before!

I would also add as part of your NCR;

  1. Conduct an internal audit of the program so that you can identify other potential faults that may cause a safety threat to the business.
  2. As part of your program, ensure that you have a risk assessment completed that explains why samples must be completed twice monthly compared to once a month, or once every two months etc.
  3. Add your findings into management report and or ensure that you have had a management report to show that the NCR was discussed with actions raised. 

Auditors should not be feared, their job is to verify that the company is complying to the requirements and honesty is always best.

Sampling is only a fraction of the requirements too, so ensure that you are covered on the critical elements such as management meetings, objectives, GMP, training etc and you will do well. 

 

All the best!



renzr79

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Posted 20 January 2021 - 02:05 PM

I think it is necessary to post an update and close this matter. I would like to appreciate everyone's input and feedback. It is my pleasure to inform that I'm still employed at my facility. We had our SQF audit on Jan 12-14 (2.5 days) and my first time defending a GFSI scheme, ever. We score a 98 (E)! It is the first time the facility scores a 98, the highest being 97. back in 2019. On this audit there were 2 minor non-conformities in module 2, no nc in module 11, and no nc in the Quality code.



TimG

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Posted 20 January 2021 - 02:34 PM

Very nice,

Congratulations!



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Charles.C

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Posted 20 January 2021 - 02:42 PM

I think it is necessary to post an update and close this matter. I would like to appreciate everyone's input and feedback. It is my pleasure to inform that I'm still employed at my facility. We had our SQF audit on Jan 12-14 (2.5 days) and my first time defending a GFSI scheme, ever. We score a 98 (E)! It is the first time the facility scores a 98, the highest being 97. back in 2019. On this audit there were 2 minor non-conformities in module 2, no nc in module 11, and no nc in the Quality code.

 

Hi renzr,

 

Thanks for the update. Congratulations !.

 

Looks like the auditor ignored the discrepancy detailed in yr OP ?


Kind Regards,

 

Charles.C


Setanta

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Posted 20 January 2021 - 02:50 PM

Congratulations!!


-Setanta         

 

 

 


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renzr79

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Posted 20 January 2021 - 04:24 PM

Hi renzr,

 

Thanks for the update. Congratulations !.

 

Looks like the auditor ignored the discrepancy detailed in yr OP ?

 

No, the matter was not ignored. We were able to defend the issue with a detailed CAPA plan addressing it. We also provided evidence of the robust sanitation program, no history of FS complaints, 3rd party lab negative results after the program was reestablished, and 3rd party lab negative results of finished products since the program was compromised. There was a lot of talk and the auditor concluded there was still a bit of uncertainty, but the "0" FS complaints, negative results on EM samples for subsequent months, and negative results on all finished products samples were able to appease his concern. So, it went by with a slap to the hand.





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